预约演示
更新于：2025-02-13
Cetuximab
西妥昔单抗
更新于：2025-02-13
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 瑞士 (2003-12-01), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、优先审评 (中国) |
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结构/序列
Sequence Code 43254L
来源: *****
Sequence Code 9505399H
来源: *****
关联
1,115
项与 西妥昔单抗 相关的临床试验NCT06369259
Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination with Defactinib (FAK Inhibitor) and Cetuximab in Patients with Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer
NCT06818812
A Phase 1, Open-Label, Multicenter Study of INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
NCT06764771
A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
100 项与 西妥昔单抗 相关的临床结果
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100 项与 西妥昔单抗 相关的转化医学
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100 项与 西妥昔单抗 相关的专利（医药）
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8,099
项与 西妥昔单抗 相关的文献（医药）2025-12-01Journal of Gastrointestinal Cancer
Anti-EGFR Rechallenge in Metastatic Colorectal Cancer and the Role of ctDNA: A Systematic Review and Meta-analysis
Review
作者: da Silva, Luís Felipe Leite ; Peixoto, Renata D 'Alpino ; Saldanha, Erick Figueiredo ; da Conceição, Lucas Diniz ; Noronha, Mariana Macambira ; da Silva, Marcos Vinícius Martins Grangeiro
BACKGROUND:
Metastatic colorectal cancer (mCRC) remains a significant clinical challenge. While anti-EGFR inhibitors have improved survival rates, their long-term efficacy is limited by disease progression, which is often associated with the development of acquired resistance mutations. However, some patients may regain sensitivity to anti-EGFR agents after alternative therapies, suggesting a potential benefit for rechallenge strategies. Our study aims to conduct a systematic review and meta-analysis to comprehensively evaluate the efficacy and safety of EGFR rechallenge in patients with mCRC.
METHODS:
A systematic search of the MEDLINE, EMBASE, and Cochrane databases was conducted between October 28 and December 24, 2023, to identify clinical trials investigating treatment regimens incorporating panitumumab or cetuximab as a rechallenge strategy. Pooled proportions or hazard ratios (HR) were calculated using a random effects model. Inter-study heterogeneity was assessed using the I2.
RESULTS:
Among the 2105 articles identified through the search, 13 met the predetermined inclusion criteria. Of these, 12 were phase II studies, encompassing 92.3% of the patient population. Cetuximab was administered to 302 patients (75.1%), whereas panitumumab was utilized in 100 patients (24.9%).A pooled analysis of eight studies demonstrated an objective response rate of 20.50% (95% CI 7.94 to 33.07) and a disease control rate of 67.35% (95% CI 58.60 to 76.09). The median progression-free survival was estimated at 3.5 months (95% CI 2.68-6.69), with a median OS of 9.8 months (95% CI 6.71-12.89). Patients exhibiting RAS wild-type status in circulating tumor DNA (ctDNA) analysis derived enhanced benefits from anti-EGFR rechallenge (HR: 0.41; 95% CI 0.28-0.60, I2 = 60%). Common grade 3 or higher treatment-related adverse events included neutropenia (22.8%) and rash (14.9%).
CONCLUSION:
This meta-analysis underscores the efficacy and safety of anti-EGFR rechallenge as a promising therapeutic approach for a subset of patients afflicted with mCRC. The observed correlation between wild-type RAS status, as determined through ctDNA analysis, and improved OS signals the prospect of precision oncology in guiding treatment decisions.
2025-12-01Journal of Gastrointestinal Cancer
Efficacy and Safety of Anti-EGFR Therapy Rechallenge in Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis
Review
作者: Burbano, Rommel Mario Rodríguez ; de Oliveira Rodrigues, Anna Luíza Soares ; de Moraes, Francisco Cezar Aquino ; Limachi-Choque, Jhonny ; Priantti, Jonathan N
BACKGROUND:
Colorectal cancer (CRC) represents the second leading cause of cancer-related mortality worldwide, with a significant portion of patients presenting with metastatic disease at diagnosis. Resistance to initial anti-EGFR therapy, a key treatment for RAS wild-type metastatic CRC, remains a major challenge. This study aimed to assess the efficacy and safety of rechallenge with anti-EGFR therapy in patients with metastatic CRC who have progressed after prior treatments.
METHODS:
A systematic search was conducted across PubMed, Web of Science, Cochrane, and Scopus. Studies were included if they were randomized controlled trials (RCTs) or observational studies involving patients with EGFR-mutated metastatic CRC who received anti-EGFR therapy as a rechallenge. Endpoints included objective response rate (ORR), disease control rate (DCR), and the incidence of adverse events. Statistical analyses were performed using the DerSimonian/Laird random effect model, with heterogeneity assessed via I2 statistics. R, version 4.2.3, was used for statistical analyses.
RESULTS:
Fourteen studies were included with 520 patients; 50.3% were male, and the median age was 63 years old. The median progression-free survival (mPFS) ranged between 2.4 and 4.9 months, while the median overall survival (mOS) ranged from 5 to 17.8 months. Our pooled analysis demonstrated an objective response rate (ORR) of 17.70% (95% CI, 8.58-26.82%) and a disease control rate (DCR) of 61.72% (95% CI, 53.32-70.11%), both with significant heterogeneity (I2, 84% and 80%, respectively; p < 0.01). In the subgroup analysis, cetuximab showed an ORR of 18.31% (95% CI, 4.67-31.94%), and panitumumab an ORR of 10.9% (95% CI, 0.00-26.82%), while the combination of both resulted in an ORR of 29.24% (95% CI, 0.00-65.84%). For DCR, cetuximab resulted in 62.1% (95% CI, 49.32-74.87%), panitumumab in 63.05% (95% CI, 52.13-73.97%), and the combination in 60.34% (95% CI, 31.92-88.77%), all with significant heterogeneity. Adverse events included anemia (15.39%), diarrhea (4.20%), hypomagnesemia (6.40%), neutropenia (22.57%), and skin rash (13.22%).
CONCLUSIONS:
Rechallenge with anti-EGFR therapy in metastatic CRC patients shows moderate efficacy with manageable safety profiles. These findings highlight the need for careful patient selection and monitoring to optimize outcomes. Further studies are warranted to refine strategies for maximizing the therapeutic benefits of anti-EGFR rechallenge.
2025-03-01Molecular Therapy: Oncology
Enhancing NK cell-mediated tumor killing of B7-H6+ cells with bispecific antibodies targeting allosteric sites of NKp30
Article
作者: Pekar, Lukas ; Toleikis, Lars ; Kolmar, Harald ; Becker, Stefan ; Zielonka, Stefan ; Fournier, Léxane ; Arras, Paul
In this work, we report the discovery and engineering of allosteric variable domains of the heavy chain (VHHs) derived from camelid immunization targeting NKp30, an activating receptor on natural killer (NK) cells. The aim was to enhance NK cell-mediated killing capacities by identifying VHHs that do not compete with the natural ligand of NKp30:B7-H6, thereby maximizing the recognition of B7-H6+ tumor cells. By relying on the DuoBody technology, bispecific therapeutic antibodies were engineered, creating a panel of bispecific antibodies against NKp30xEGFR (cetuximab moiety) or NKp30xHER2 (trastuzumab moiety), called natural killer cell engagers (NKCEs). These NKCEs were assessed for their killing capacities on B7-H6-expressing tumor cells. The results demonstrated an enhancement in NK killing capacities for both EGFR-expressing (HeLa) and HER2-expressing (SK-BR-3) cells, indicating the significance of the natural NKp30/B7-H6 axis in tumor recognition by the immune system. Notably, engineering NKCEs to allow natural recognition of B7-H6 was found to be more effective in promoting NKCE-mediated killing of B7-H6+ tumor cells via enhancement of cytokine release. This study highlights the potential of an enhanced-targeting approach, wherein tumor cell surface antigens are targeted while still enabling the natural recognition of the activating ligand (B7-H6) by the immune cells.
100 项与 西妥昔单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| RAS 野生型结直肠癌 | 澳大利亚 | 2007-09-25 | |
| 头颈部肿瘤 | 美国 | 2006-03-01 | |
| 转移性结直肠癌 | 欧盟 | 2004-06-29 | |
| 转移性结直肠癌 | 冰岛 | 2004-06-29 | |
| 转移性结直肠癌 | 列支敦士登 | 2004-06-29 | |
| 转移性结直肠癌 | 挪威 | 2004-06-29 | |
| 头颈部鳞状细胞癌 | 欧盟 | 2004-06-29 | |
| 头颈部鳞状细胞癌 | 冰岛 | 2004-06-29 | |
| 头颈部鳞状细胞癌 | 列支敦士登 | 2004-06-29 | |
| 头颈部鳞状细胞癌 | 挪威 | 2004-06-29 | |
| 结直肠癌 | 瑞士 | 2003-12-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| KRAS G12C突变结直肠癌 | 临床3期 | 美国 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 中国 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 阿根廷 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 澳大利亚 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 奥地利 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 比利时 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 巴西 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 加拿大 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 哥伦比亚 | 2021-06-24 | |
| KRAS G12C突变结直肠癌 | 临床3期 | 捷克 | 2021-06-24 |
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临床结果
临床结果
适应症
分期
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临床3期 | 479 | 衊衊範蓋願鏇顧齋構築(鑰顧積顧糧憲餘餘積醖) = 顧鏇襯觸簾窪糧夢範構 積選積網襯網選醖醖獵 (觸積簾鬱衊蓋夢簾鹹鑰, 51.6 ~ 69.5) 更多 | 积极 | 2025-01-23 | |||
衊衊範蓋願鏇顧齋構築(鑰顧積顧糧憲餘餘積醖) = 餘鏇製襯網衊窪廠構顧 積選積網襯網選醖醖獵 (觸積簾鬱衊蓋夢簾鹹鑰, 31.3 ~ 49.3) 更多 | |||||||
临床2期 | BRAF V600E突变结直肠癌 BRAF V600E mutated | 20 | Cetuximab every second week + Encorafenib | 選糧艱膚窪餘構顧廠鏇(齋淵簾蓋醖窪糧醖網糧) = 網構壓網簾鹽廠範襯膚 淵築窪網觸膚網選廠繭 (糧窪鹽鏇築蓋積網淵鹹 ) | 积极 | 2025-01-23 | |
临床2期 | 31 | 選衊鏇網窪憲鬱積襯鑰(憲願鬱製壓醖範壓艱顧) = 鹹選製顧遞廠鏇選積選 選製夢廠願願鑰廠顧憲 (簾顧夢簾繭範齋襯膚窪, 3.2 ~ 12.0) 更多 | 积极 | 2024-12-07 | |||
临床2/3期 | 186 | 淵鹹範醖醖遞獵鬱構鹹(憲獵遞觸獵憲繭願鹹鏇) = The most common grade 3-4 adverse events were dysphagia (26 [22%] of 119 patients in the durvalumab group vs 18 [30%] of 61 patients in the cetuximab group), lymphopenia (33 [28%] vs 20 [33%]), and oral mucositis (13 [11%] vs 11 [18%]). 壓顧壓鑰廠網網顧衊鑰 (醖選鹽選選蓋獵膚觸齋 ) 更多 | 不佳 | 2024-12-01 | |||
SITC2024 人工标引  | 临床1期 | 结直肠癌 Proficient DNA Mismatch Repair (pMMR) | 15 | pre-A+E CBNK cells + cetuximab | 製夢製鑰顧襯餘遞願膚(齋齋遞積獵艱遞襯壓顧) = None 齋襯餘廠觸繭夢簾顧夢 (鑰範鏇繭淵鑰觸範鬱獵 ) 更多 | 积极 | 2024-11-05 |
临床1期 | 76 | SAR444881 monotherapy | 廠憲淵顧艱膚廠觸繭夢(鑰餘鹽築襯築鬱顧積構) = 19% 鏇鏇廠獵壓淵鬱選蓋選 (鹹夢艱鬱築製觸築構網 ) 更多 | 积极 | 2024-11-05 | ||
临床2期 | 22 | (Arm A (Regorafenib)) | 襯蓋願憲夢鏇積餘鬱簾(廠獵餘網積壓製鹹遞壓) = 衊觸鹹構襯製鹽簾鬱選 糧鬱蓋淵選鹹鬱鏇顧齋 (積憲簾齋觸齋觸衊廠鬱, 廠蓋築繭膚築壓築蓋鹹 ~ 壓獵製選醖鹹繭鬱製餘) 更多 | - | 2024-09-27 | ||
(Arm B (Cetuximab, Panitumumab, Irinotecan)) | 襯蓋願憲夢鏇積餘鬱簾(廠獵餘網積壓製鹹遞壓) = 繭襯蓋積製觸構齋願製 糧鬱蓋淵選鹹鬱鏇顧齋 (積憲簾齋觸齋觸衊廠鬱, 遞餘衊夢淵鹹鏇網襯夢 ~ 鑰齋選餘築蓋糧淵窪壓) 更多 | ||||||
临床3期 | 80 | Cetuximab + Capecitabine | 鑰憲鹹鑰壓廠壓衊壓夢(壓繭鬱醖襯夢夢鹽網鏇) = 壓壓構淵積齋夢築構鬱 顧糧憲構襯窪觸鑰壓夢 (衊範鬱構膚選簾獵襯簾, 5.32 ~ 11.24) 更多 | 积极 | 2024-09-16 | ||
鑰憲鹹鑰壓廠壓衊壓夢(壓繭鬱醖襯夢夢鹽網鏇) = 衊糧淵鑰淵壓窪膚簾範 顧糧憲構襯窪觸鑰壓夢 (衊範鬱構膚選簾獵襯簾, 3.02 ~ 7.46) 更多 | |||||||
临床3期 | 701 | 鹽衊範蓋襯襯獵膚廠選(夢壓襯遞觸鏇窪網選觸) = 憲鬱蓋衊壓蓋醖鏇築艱 夢網製構餘齋衊鏇積鹽 (製獵繭艱餘醖構範餘鬱, 26.2 ~ 42.2) | 不佳 | 2024-09-14 | |||
SOC-cetuxcetuximab | 鹽衊範蓋襯襯獵膚廠選(夢壓襯遞觸鏇窪網選觸) = 齋鬱鑰糧觸願窪鏇鹹齋 夢網製構餘齋衊鏇積鹽 (製獵繭艱餘醖構範餘鬱, 12.5 ~ 26.1) | ||||||
临床1/2期 | 43 | 壓選鹹糧膚鏇範觸糧選(壓簾窪壓憲製選鑰壓積) = 簾鹹壓夢鹽繭廠衊構齋 壓選範艱餘網窪鹹糧遞 (餘糧觸遞鑰製簾憲壓衊, 27.0 ~ 57.9) 更多 | 积极 | 2024-09-14 |
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